LaparoscopicNCT04546230
Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.
A study testing Low-Thoracic Epidural Anesthesia and General Anesthesia in people with Laparoscopic and Nephrectomy, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic, Nephrectomy, Anesthesia
- What is being tested?
- Low-Thoracic Epidural Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Sep 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I - II.
- Adult patients scheduled for laparoscopic nephrectomy.
Who cannot join
- Patient refusal.
- Contraindication to regional anesthesia (e.g., coagulopathy, site infection).
- Allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo
Nazmy S Michael, MD, 01227400808 ext. +2, nazmy.seif@gmail.com
Atef K Salama, MD, 01001155851 ext. +2, atef.kamel@kasralainy.edu.eg
About this study
Official title: Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy In Adult Patients.
Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and outcomes similar to that of open surgery.
Recently, advanced laparoscopic surgery has targeted older and high risk patients for general anesthesia; in these patients, regional anesthesia offers several advantages with improved patient satisfaction. Compared with alternative anesthetic techniques, epidural anesthesia may reduce the risks of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression and renal failure.
The aim of this study is to compare the conventional general anesthetic technique to the regional anesthesia for laparoscopic nephrectomy, in modified lateral decubitus position using low-pressure pneumoperitoneum.
- Conditions
- Laparoscopic, Nephrectomy, Anesthesia, Epidural
- Being tested
- Low-Thoracic Epidural Anesthesia, General Anesthesia
- Keywords
- Epidural Anesthesia, Low-thoracic, Laparoscopic nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Thoracic Epidural AnesthesiaProcedure or surgery
Under aseptic conditions and local anesthesia, an epidural catheter will be inserted using the "Prefix Epidural Anesthesia Tray" with an 18 G Tuohy needle \& a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place.
Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as a continuous infusion to be started 1 hour later \& continued throughout the procedure.
General AnesthesiaProcedure or surgery
General anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen \& infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided.
| Study group | Role | What they receive |
|---|---|---|
| E group | Experimental | Low-Thoracic Epidural Anesthesia Receives: Procedure: Low-Thoracic Epidural Anesthesia |
| G group | Active comparator | General Anesthesia Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction.
The overall degree of patients' satisfaction will be assessed using a "5-point patient satisfaction rating scale" according to Likert scale [where: very unsatisfied=1/5, unsatisfied=2/5, neutral=3/5, satisfied=4/5, and very satisfied=5/5].
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start19 Sep 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Nazmy S Michael, MD, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityAtef K Salama, MD, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546230
- Sponsor's protocol ID
- LTEALN
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy In Adult Patients.
- ClinicalTrials.gov ID
- NCT04546230
- Acronym / sponsor ID
- LTEALN
- Conditions
- Laparoscopic, Nephrectomy, Anesthesia, Epidural
- Keywords
- Epidural Anesthesia, Low-thoracic, Laparoscopic nephrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and outcomes similar to that of open surgery.
Recently, advanced laparoscopic surgery has targeted older and high risk patients for general anesthesia; in these patients, regional anesthesia offers several advantages with improved patient satisfaction. Compared with alternative anesthetic techniques, epidural anesthesia may reduce the risks of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression and renal failure.
The aim of this study is to compare the conventional general anesthetic technique to the regional anesthesia for laparoscopic nephrectomy, in modified lateral decubitus position using low-pressure pneumoperitoneum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E group | Experimental | Procedure: Low-Thoracic Epidural AnesthesiaLow-Thoracic Epidural Anesthesia |
| G group | Active comparator | Procedure: General AnesthesiaGeneral Anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I - II.
- Adult patients scheduled for laparoscopic nephrectomy.
Key exclusion criteria (3 listed)
- Patient refusal.
- Contraindication to regional anesthesia (e.g., coagulopathy, site infection).
- Allergy to local anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Thoracic Epidural AnesthesiaUnder aseptic conditions and local anesthesia, an epidural catheter will be inserted using the "Prefix Epidural Anesthesia Tray" with an 18 G Tuohy needle \& a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place. Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as a continuous infusion to be started 1 hour later \& continued throughout the procedure. | Procedure or surgery | E group |
| General AnesthesiaGeneral anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen \& infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided. | Procedure or surgery | G group |
Primary outcome
Overall patient satisfaction.
Time frame: 24 hours
The overall degree of patients' satisfaction will be assessed using a "5-point patient satisfaction rating scale" according to Likert scale [where: very unsatisfied=1/5, unsatisfied=2/5, neutral=3/5, satisfied=4/5, and very satisfied=5/5].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nazmy S Michael, MD principal investigator
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Atef K Salama, MD study director
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Thoracic Epidural Anesthesia and General Anesthesia in people with Laparoscopic and Nephrectomy, run by Nazmy Edward Seif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazmy S Michael, MD (01227400808 ext. +2, nazmy.seif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient satisfaction. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.